drugset / Trial / NCT02547220

A Multicenter Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Participants With Kidney Transplant

NCT02547220

Phase 3 Terminated 39 enrolled Shire
RandomizedParallel-groupTriple-blindTreatment

Summary

The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft in kidney transplant recipients as measured by the proportion of participants with new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.

Timeline

Start
2016-05-20
Primary completion
2019-05-31
Completion
2019-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CINRYZE Protein / enzyme biologic 2500 iu